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A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

NCT05048797 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2026-04-03

No results posted yet for this study

Summary

DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

Conditions

Interventions

DRUG

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan administered by intravenous infusion

DRUG

Cisplatin

Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion

DRUG

Carboplatin

Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion

DRUG

Pembrolizumab

Pembrolizumab administered by intravenous infusion

DRUG

Pemetrexed

Pemetrexed administered by intravenous infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
123 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2026-04-30
Completion
2027-07-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Hong Kong
  • India
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05048797 on ClinicalTrials.gov